Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 12786efd-df42-4321-bfdf-88f542d387bb
Route
ORAL
Published
Effective Date 2024-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Garlic (3 [hp_X]) Berberis Vulgaris Root Bark (6 [hp_X]) Fucus Vesiculosus (12 [hp_X]) Phytolacca Americana Root (16 [hp_X]) Silver Gold Fluoride Ion Calcium Cation Hekla Lava Iodine Mercurius Solubilis Nickel Silicon Dioxide Zinc Platinum
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-10-06

Description

(in each drop) Argentum Metallicum 12X 7.67%, Aurum Metallicum 12X 7.67%, Calcarea Fluorica 12X 7.67%, Calcarea Phosphorica 12X 7.67%, Hekla Lava 12X 7.67%, Hydrofluoricum Acidum 12X 7.67%, Iodium 12X 7.67%, Mercurius Solubilis 12X 7.67%, Niccolum Metallicum 12X 7.67%, Phytolacca Decandra 6X 7.67%, Platinum Metallicum 16X 7.67%, Silicea 12X 7.67%, Zincum Metallicum 12X 7.67%, Allium Sativum 3X 0.10%, Berberis Vulgaris 3X 0.10%, Fucus Vesiculosus 3X 0.10%.

Purpose

Argentum Metallicum – bruised pains**, Aurum Metallicum – foul breath**, Calcarea Fluorica – sensitive teeth**, Calcarea Phosphorica – bitter taste**, Hekla Lava – toothache**, Hydrofluoricum Acidum – sore mouth**, Iodium – sweetish taste**, Mercurius Solubilis – metallic taste**, Niccolum Metallicum – stiff tongue**, Phytolacca Decandra – lymphatic congestion**, Platinum Metallicum – tongue pain**, Silicea - dry mouth**, Zincum Metallicum – bleeding gums**, Allium Sativum – swollen gums**, Berberis Vulgaris – thick saliva**, Fucus Vesiculosus – neck swelling**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Argentum Metallicum – bruised pains**, Aurum Metallicum – foul breath**, Calcarea Fluorica – sensitive teeth**, Calcarea Phosphorica – bitter taste**, Hekla Lava – toothache**, Hydrofluoricum Acidum – sore mouth**, Iodium – sweetish taste**, Mercurius Solubilis – metallic taste**, Niccolum Metallicum – stiff tongue**, Phytolacca Decandra – lymphatic congestion**, Platinum Metallicum – tongue pain**, Silicea - dry mouth**, Zincum Metallicum – bleeding gums**, Allium Sativum – swollen gums**, Berberis Vulgaris – thick saliva**, Fucus Vesiculosus – neck swelling**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) Argentum Metallicum 12X 7.67%, Aurum Metallicum 12X 7.67%, Calcarea Fluorica 12X 7.67%, Calcarea Phosphorica 12X 7.67%, Hekla Lava 12X 7.67%, Hydrofluoricum Acidum 12X 7.67%, Iodium 12X 7.67%, Mercurius Solubilis 12X 7.67%, Niccolum Metallicum 12X 7.67%, Phytolacca Decandra 6X 7.67%, Platinum Metallicum 16X 7.67%, Silicea 12X 7.67%, Zincum Metallicum 12X 7.67%, Allium Sativum 3X 0.10%, Berberis Vulgaris 3X 0.10%, Fucus Vesiculosus 3X 0.10%.

Uses:

May temporarily relieve symptoms associated with dental procedures, such as: pain and minor swelling in the mouth or on the gums.**

** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purposes:

Argentum Metallicum – bruised pains**, Aurum Metallicum – foul breath**, Calcarea Fluorica – sensitive teeth**, Calcarea Phosphorica – bitter taste**, Hekla Lava – toothache**, Hydrofluoricum Acidum – sore mouth**, Iodium – sweetish taste**, Mercurius Solubilis – metallic taste**, Niccolum Metallicum – stiff tongue**, Phytolacca Decandra – lymphatic congestion**, Platinum Metallicum – tongue pain**, Silicea - dry mouth**, Zincum Metallicum – bleeding gums**, Allium Sativum – swollen gums**, Berberis Vulgaris – thick saliva**, Fucus Vesiculosus – neck swelling**.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Stop use and ask a doctor if symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING. Store in a cool, dry place.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Directions:

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. 

• Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each drop) Argentum Metallicum 12X 7.67%, Aurum Metallicum 12X 7.67%, Calcarea Fluorica 12X 7.67%, Calcarea Phosphorica 12X 7.67%, Hekla Lava 12X 7.67%, Hydrofluoricum Acidum 12X 7.67%, Iodium 12X 7.67%, Mercurius Solubilis 12X 7.67%, Niccolum Metallicum 12X 7.67%, Phytolacca Decandra 6X 7.67%, Platinum Metallicum 16X 7.67%, Silicea 12X 7.67%, Zincum Metallicum 12X 7.67%, Allium Sativum 3X 0.10%, Berberis Vulgaris 3X 0.10%, Fucus Vesiculosus 3X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DENTASTAT

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses: (USES:)

May temporarily relieve symptoms associated with dental procedures, such as: pain and minor swelling in the mouth or on the gums.**

** Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purposes: (PURPOSES:)

Argentum Metallicum – bruised pains**, Aurum Metallicum – foul breath**, Calcarea Fluorica – sensitive teeth**, Calcarea Phosphorica – bitter taste**, Hekla Lava – toothache**, Hydrofluoricum Acidum – sore mouth**, Iodium – sweetish taste**, Mercurius Solubilis – metallic taste**, Niccolum Metallicum – stiff tongue**, Phytolacca Decandra – lymphatic congestion**, Platinum Metallicum – tongue pain**, Silicea - dry mouth**, Zincum Metallicum – bleeding gums**, Allium Sativum – swollen gums**, Berberis Vulgaris – thick saliva**, Fucus Vesiculosus – neck swelling**.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Stop use and ask a doctor if symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN OR MISSING. Store in a cool, dry place.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Directions: (DIRECTIONS:)

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. 

• Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Argentum Metallicum 12X 7.67%, Aurum Metallicum 12X 7.67%, Calcarea Fluorica 12X 7.67%, Calcarea Phosphorica 12X 7.67%, Hekla Lava 12X 7.67%, Hydrofluoricum Acidum 12X 7.67%, Iodium 12X 7.67%, Mercurius Solubilis 12X 7.67%, Niccolum Metallicum 12X 7.67%, Phytolacca Decandra 6X 7.67%, Platinum Metallicum 16X 7.67%, Silicea 12X 7.67%, Zincum Metallicum 12X 7.67%, Allium Sativum 3X 0.10%, Berberis Vulgaris 3X 0.10%, Fucus Vesiculosus 3X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

DENTASTAT

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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